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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02782702
Date of registration:	20/05/2016
Prospective Registration:	No
Primary sponsor:	University Hospital, Toulouse
Public title:	Evaluation of the Improvement of Quality of Life of Patients Suffering From Hailey Hailey or Darier Disease After Injections of Botulism Toxin Into Large Folds. ToxHD
Scientific title:	Evaluation of the Improvement of Quality of Life of Patients Suffering From Hailey Hailey or Darier Disease After Injections of Botulism Toxin Into Large Folds. Toxin Hailey Darier
Date of first enrolment:	September 2015
Target sample size:	30
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02782702
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	Phase 1

Countries of recruitment

Contacts

Name:	Aude MAZA RIOLAND, MD
Address:
Telephone:
Email:
Affiliation:	University Hospital, Toulouse

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis (clinical and histological features) of Hailey Hailey or Darier
diseases.

- Moderate to very severe lesions located in large folds

- Patient aged 18 ans or more

- Patient with health coverage

- Patient who have signed the consent form

- Patient proficient into filling out the questionnaires.

Exclusion Criteria:

- Hypersensibility to toxin or excipients

- Myastheny

- Deglutition's problems

- Past medical history of dysphagia or aspiration pneumonia

- Pregnancy (positive B-HCG test performed a maxima 72h before) or breastfeeding

- Mental , physical incapacity to fill in the questionnaires

- Guardianship patients

- Skin infections at the inclusion visit

- Application in the last 7 days at the site of injection of local treatments (apart
emollients or antiseptics) or injections of botulism toxin or dynamic phototherapy or
laser in the last 6 months.

- Systemic treatment with aminosides in the last 15 days

- Inclusion in another study in the last 2 months.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hailey-Hailey Disease

Darier Disease

Intervention(s)

Drug: Botulism Toxin Treatment

Primary Outcome(s)

Evaluation of quality of life measured by change in the DLQI score [Time Frame: Day 0 and day 30]

Secondary Outcome(s)

Evaluation of acceptability over the medium to long term as assessed by occurence of side effects [Time Frame: Day 180]

Evaluation of patient's satisfaction Using the IGA score " Improvement Global Assessment " [Time Frame: Day 180]

Evaluation of skin improvement in treated areas using change the IGA score [Time Frame: Day 0 and Day 90]

Evaluation of long term efficacy as assessed by comparison between the number of infection episodes occurred during the 6 months before the study or during the 6 months of the study [Time Frame: Up to 180 days]

Evaluation of psychosocial impairment measured by change in the HidroQoL score [Time Frame: Day 0 and Day 90]

Evaluation of skin improvement in treated areas using change the IGA score [Time Frame: Day 0 and Day 180]

Evaluation by the investigator of the treated lesions global severity change as assessed by comparison using measurement of the affected area [Time Frame: Day 0 and Day 30]

Evaluation of long term efficacy as assessed by delay for significant relapse (reappearance of skin lesions justifying treatment) [Time Frame: Up to 180 days]

Evaluation of patient treatment acceptability using visual analogic pain scale [Time Frame: Day 0 after injection]

Evaluation of psychosocial impairment at measured by change in the HidroQoL score [Time Frame: Day 0 and Day 30]

Evaluation by the investigator of the treated lesions global severity change as assessed by comparison using measurement of the affected area [Time Frame: Day 0 and Day 90]

Evaluation of long term efficacy as assessed by percentage of non-responder patients with IGA score egal to 0 [Time Frame: Day 30]

Evaluation of psychosocial impairment measured by change in the HidroQoL score [Time Frame: Day 0 and Day 180]

Evaluation of skin improvement in treated areas using change the IGA score [Time Frame: Day 0 and Day 30]

Evaluation of acceptability over the medium to long term as assessed by occurence of side effects [Time Frame: Day 30]

Evaluation of acceptability over the medium to long term as assessed by occurence of side effects [Time Frame: Day 90]

Evaluation of quality of life measured by change in the DLQI score [Time Frame: Day 0 and day 90]

Evaluation by the investigator of the treated lesions global severity change as assessed by comparison using measurement of the affected area [Time Frame: Day 0 and Day 180]

Evaluation of quality of life measured by change in the DLQI score [Time Frame: Day 0 and day 180]

Secondary ID(s)

14 7316 02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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